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**Recombinant human Factor IX** is a purified glycoprotein produced via recombinant DNA technology in mammalian cell lines, such as Chinese hamster ovary (CHO) cells, mimicking the structure and function of endogenous plasma-derived Factor IX, including the Ala148 allelic form. It serves as **enzyme replacement therapy** for hemophilia B (congenital Factor IX deficiency, also known as Christmas disease), temporarily restoring hemostasis by enabling the coagulation cascade: it binds vitamin K and Factor VIIIa, cleaving the Arg-Ile bond in Factor X to generate active Factor Xa, which promotes clot formation and shortens prolonged activated partial thromboplastin time (aPTT). Administered intravenously for on-demand bleeding control, perioperative management, and routine prophylaxis to reduce bleeding frequency in adults and children; variants like Fc fusion (e.g., Alprolix) or PEGylated forms extend half-life via FcRn recycling or PEGylation.[1][2][3][7][9]
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